MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-88-60

Device Problem Pumping Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a s5 mast roller pump displayed a motor control failure error message and stopped after start-up.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H10: a review of the dhr could not identify any deviations or nonconformities relevant to the issue.The unit was requested back to the manufacturer site for investigation.The failure was reproduced.Internal visual inspection revealed corroded soldering joints on both the motor control and power amplifier boards.The root cause of the reported event was traced back to fluid ingress into the pump which led to joint's corrosion and consequent hardware failure of the boards.An inadequate cleaning by the user may most likely caused the reported event.Instruction for use cp_ifu_5811-0000 recommend the user to make sure that no liquids enter the machine housing and to not use sprays during the cleaning procedure.

• Brand Name: S5 MAST ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309
• MDR Report Key: 10195782
• MDR Text Key: 197157467
• Report Number: 9611109-2020-00368
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-88-60
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1